Pivotal Clinical Data Published for the Only Laser Phototherapy Device Cleared by...

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Mon Apr 20, 2009 6:45am EDT

Pivotal Clinical Data Published for the Only Laser Phototherapy Device Cleared
by the FDA for Hair Growth

- Study provides clinical efficacy of the HairMax LaserComb in the treatment
of Androgenetic Alopecia in males commonly known as 'male pattern baldness' -

BOCA RATON, Fla., April 20 /PRNewswire/ -- Findings of the pivotal clinical
trial of the HairMax LaserComb that provided clear evidence of efficacy and
safety to the U.S. Food and Drug Administration will be published in the
prestigious peer review journal, Clinical Drug Investigation in May 2009.
Results of the clinical trial were a key factor in the clearance of the device
for marketing in January 2007 for the promotion of hair growth in males with
Androgenetic Alopecia.

The six-month study, titled, "HairMax LaserComb(R) Laser Phototherapy Device
in the Treatment of Male Androgenetic Alopecia," demonstrates that the device
should be considered as first line therapy for all appropriate men with this
condition.

According to Mr. Leonard Stillman, Director of Professional Services at
Lexington International, "This is the first controlled clinical trial
published that proved the clinical efficacy and safety of a laser phototherapy
device for treating hereditary hair loss."

Clinical assessment of treated scalp sites was carried out by objective
evaluation of macro-images using dot mapping and computer aided hair counts,
and with subjective evaluations by physicians and patients.

The study showed that the HairMax LaserComb is an effective and well-tolerated
laser phototherapy device for the treatment of certain classes of Androgenetic
Alopecia in males.

The adverse event profile was similar in the two treatment groups and there
were no reports of serious adverse events.

According to Mr. Stillman, "The HairMax LaserComb was introduced to the
medical community in 2007. Since then, a large number of dermatologists have
adopted the device for their patients and it has become a mainstay in their
treatment protocols for this psychologically distressing condition." 

Mr. Stillman also noted that male pattern baldness affects more than 50
million men in the U.S. and many more millions of men worldwide.

Study Design and Results

The four-center, double-blind, sham-device (placebo), controlled study was
designed to compare the results of treatment of subjects randomized in a
blinded fashion to either the HairMax LaserComb or the sham-device per a
protocol approved by an Investigational Review Board (IRB) and performed in
accordance with Good Clinical Practices. Subjects were required to have a
Norwood Hamilton classification of IIa to V based on the Male Classification
System of Hair Loss, and have Fitzpatrick Skin Type Scale I through IV. 

Of the patients who completed the six-month study, subjects in the HairMax
LaserComb treatment group exhibited significantly greater increase in mean
terminal hair density than that seen in subjects treated with the sham-device.

Mr. Stillman further commented, "The results of the study accomplished an
important goal. By conducting a well-designed and controlled efficacy trial,
results showed that the HairMax LaserComb is truly an effective, convenient,
well-tolerated treatment for hair loss caused by Androgenic Alopecia in
males." 

About the HairMax LaserComb

The laser energy emitted by the HairMax LaserComb is hypothesized to increase
the biological molecule ATP which in turn increases cellular metabolism and
cellular activity. The hair follicle then has the building blocks and energy
to transform from a weakened follicle to one that is healthy and capable of
producing thick terminal hair. The enhanced environment in turn invigorates
the hair follicle which produces healthier hair, prevents further hair loss
and stimulates the re-growth of thicker terminal hair.

The HairMax LaserComb utilizes a patented 'teeth' mechanism to part the hair
to allow the laser energy to penetrate the scalp into the hair follicles. Many
hair loss sufferers now have newfound hope in their battle to overcome hair
loss. The HairMax LaserComb treatment is easy to use, only 10 to 15 minutes
three times per week on their own schedule and in the comfort and privacy of
their homes.

About Lexington International, LLC 
Based in Boca Raton, Fla., Lexington International manufactures and
distributes the HairMax LaserComb(R) (www.hairmax.com) to more than 90
countries and has provided new hope and satisfaction to tens of thousands of
customers since 2001. The HairMax LaserComb is based on 20 years of
international research and studies on the effects of Low Level Laser use. Both
the press and users alike have universally taken to the HairMax LaserComb.
Coverage has included Dateline NBC, TIME Magazine, as one of their "Inventions
of the Year," as well as the November 2004 issue of Good Housekeeping
Magazine. Lexington is a proud member of "Team Florida" and has participated
in high-level, overseas trade missions with Governor Jeb Bush. Additionally,
the company was awarded by the U.S. Department of Commerce for "Commercial and
Export Achievement."

EDITOR'S NOTE:  To speak with Leonard Stillman or Dr. Matt Leavitt about the
study or to learn more about the HairMax LaserComb, please call Nancy Trent or
Pam Wadler at 212-966-0024.


SOURCE  Lexington International, LLC

Nancy Trent or Pamela Wadler, both of Trent & Company, Inc for Lexington
International, +1-212-966-0024, info@trentandcompany.com
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